Five day moxifloxacin therapy compared with 7 day clarithromycin therapy for the treatment of acute exacerbations of chronic bronchitis

In this multinational, randomized, double-blind study, the efficacy and saf ety of a 5 day course of moxifloxacin 400 mg orally od was compared with th at of a 7 day course of clarithromycin 500 mg orally bd in 750 patients wit h acute exacerbations of chronic bronchitis, characterized by at least two of the symptoms: sputum purulence, increased sputum volume or increased dys pnoea. Seven days after the end of therapy, clinical cure was achieved for 89% (287 of 322) of efficacy-evaluable patients in the moxifloxacin group a nd 88% (289 of 327) of patients in the clarithromycin group (95% CI, -3.9%, 5.8%). At follow-up (21-28 days post-treatment), the continued clinical cu re rates were 89% (256 of 287) for moxifloxacin and 89% (257 of 289) for cl arithromycin. A total of 342 pathogenic bacteria were isolated from the spu tum of 287 patients. The most common pathogens were Haemophilus influenzae (37%), Streptococcus pneumoniae (31%) and Moraxella catarrhalis (18%). Seve n days post-treatment, a successful bacteriological response was obtained f or 77% (89 of 115) of patients in the moxifloxacin group and 62% (71 of 114 ) of patients in the clarithromycin group, indicating superiority of moxifl oxacin (95% CI, 3.6%, 26.9%). Both treatments were well tolerated with few adverse events. This study demonstrated that for the treatment of acute exa cerbations of chronic bronchitis a 5 day course of moxifloxacin 400 mg od w as clinically equivalent and bacteriologically superior to a 7 day course o f clarithromycin 500 mg bd.